2022 RAPS Convergence

The clinical evaluation process for medical devices has expanded from a simple process to a comprehensive justification and critical appraisal of its safety and performance. This session will review clinical evaluation requirements and discuss strategies to help you avoid questions from notified bodies- organizations in charge of the conformity assessment of medical devices before they are placed on the market or put into service.

Engaging patients, caregivers, and the general public in the clinical research arena is challenging, regardless of the therapeutic indication or patient population. Written outcomes of clinical research can and do contribute to a greater general scientific understanding, but they also can assist with future trial enrollment for all researchers and globally improve health literacy. The inclusion of a lay summary is also of vital importance to the regulatory submission for some health authorities and must be part of the trial and regulatory project planning process. Summarizing trial results for trial participants, educating the general public by production of high-quality health literacy content, and required regulatory submission content are key principles to consider for each trial. This session will highlight the types of plain language summaries (PLS) produced for audiences in the United States and The Good Lay Summary (LS) Practice for writing and submissions.